Stevens-Johnson SyndromePhase 4NCT01488396
Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
A Phase 4 study testing 0.05%cyclosporin eye drop in people with Stevens-Johnson Syndrome, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate the efficacy of 0.05% cyclosporin ophthalmic emulsion (Restasis) in patients with Stevens-Johnson syndrome that have dry eyes by subjective symptoms and signs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stevens-Johnson Syndrome
- What is being tested?
- 0.05%cyclosporin eye drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2007to Jul 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, of legal age of consent
- Patient with Stevens-Johnson syndrome in chronic stage or has symptoms more than 3 months and has dry eye symptoms
- Dry eye symptoms are defined as
- has dry eye symptom everyday for more than 3 months
- has foreign body sensation frequently
- use tear substitutes more than 3 times per day
Show all 11Show fewer
- Tear test shaw abnormalities at least 1 of 2 of following:
- Schirmer test without anesthesia is not more than 5 millimeters in 5 minutes
- Fluorescein clearance test at first 10 minutes is not more than 3 millimeters and has at least 1 of 3 of the following:
- 2.1.Rose Bengal score is not less than 4 2.2.Fluorescein stain at cornea 2.3.Impression cytology is consistent to dry eye
- Patent punctum
Who cannot join
- Age < 18 years old
- Patients with Steven Johnson syndrome without dry eye
- Patients used oral cyclosporine or anticholinergic drug within past 2 months
- Patients with HIV or immunocompromise status
- Patients with active ocular infections and patients with a history of herpes keratitis
- Patients with known or suspected hypersensitivity to any of the ingredients in the formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342)
- Female patients are pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy of 0.05% cyclosporin ophthalmic emulsion (Restasis) in patients with Stevens-Johnson syndrome that have dry eyes by subjective symptoms and signs.
Read the detailed description
Stevens-Johnson syndrome patients in chronic stage who have dry eys symptoms and signs will be treated with 0.05%cyclosporin ophthalmic emulsion(Restasis)twice a day for 6 months, compare results at 0,2,4,6 months include dry eye symptoms, corneal staining (Fluorescein, Rose Bengal), Schirmer I,FCT and impression cytology
- Conditions
- Stevens-Johnson Syndrome
- Being tested
- 0.05%cyclosporin eye drop
- Keywords
- Cyclosporin, Stevens-Johnson syndrome, Dry eye
- Medical subject headings
- Stevens-Johnson Syndrome, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.05%cyclosporin eye dropDrug
Also called cyclosporin A
use twice daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 0.05%cyclosporin eye drop | Experimental | Not described Receives: Drug: 0.05%cyclosporin eye drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
dry eyes symptoms : dryness, gritty, photophobia, burning and pain
Measured: 0, 2, 4, 6 months
Secondary outcomes (4)
Schirmer I test
Measured: 0, 6 months
Fluorescein clearance test (FCT)
Measured: 0, 6 month
Corneal staining
Staining with fluorescein and rose bengal
Measured: 0, 2, 4, 6 months
Fluorescein tear break up time
Measured: 0, 2. 4. 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startFeb 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stevens-Johnson SyndromeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinnita Prabhasawat, Mahidol University
- Investigators
- Pinnita Prabhasawat, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488396
- Sponsor's protocol ID
- 336/2549
- Status last verified
- Dec 2011
- First submitted
- 8 Nov 2010
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
- ClinicalTrials.gov ID
- NCT01488396
- Acronym / sponsor ID
- 336/2549
- Conditions
- Stevens-Johnson Syndrome
- Keywords
- Cyclosporin, Stevens-Johnson syndrome, Dry eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of 0.05% cyclosporin ophthalmic emulsion (Restasis) in patients with Stevens-Johnson syndrome that have dry eyes by subjective symptoms and signs.
Detailed description
Stevens-Johnson syndrome patients in chronic stage who have dry eys symptoms and signs will be treated with 0.05%cyclosporin ophthalmic emulsion(Restasis)twice a day for 6 months, compare results at 0,2,4,6 months include dry eye symptoms, corneal staining (Fluorescein, Rose Bengal), Schirmer I,FCT and impression cytology
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.05%cyclosporin eye drop | Experimental | Drug: 0.05%cyclosporin eye drop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males or females, of legal age of consent
- Patient with Stevens-Johnson syndrome in chronic stage or has symptoms more than 3 months and has dry eye symptoms
- Dry eye symptoms are defined as
- Tear test shaw abnormalities at least 1 of 2 of following:
- 2.1.Rose Bengal score is not less than 4 2.2.Fluorescein stain at cornea 2.3.Impression cytology is consistent to dry eye
Key exclusion criteria (7 listed)
- Age < 18 years old
- Patients with Steven Johnson syndrome without dry eye
- Patients used oral cyclosporine or anticholinergic drug within past 2 months
- Patients with HIV or immunocompromise status
- Patients with active ocular infections and patients with a history of herpes keratitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.05%cyclosporin eye dropAlso: cyclosporin Ause twice daily for 6 months | Drug | 0.05%cyclosporin eye drop |
Primary outcome
dry eyes symptoms : dryness, gritty, photophobia, burning and pain
Time frame: 0, 2, 4, 6 months
4 secondary outcomes
Schirmer I test
Time frame: 0, 6 months
Fluorescein clearance test (FCT)
Time frame: 0, 6 month
Corneal staining
Time frame: 0, 2, 4, 6 months
Fluorescein tear break up time
Time frame: 0, 2. 4. 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pinnita Prabhasawat, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.05%cyclosporin eye drop in people with Stevens-Johnson Syndrome, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dry eyes symptoms : dryness, gritty, photophobia, burning and pain (time frame: 0, 2, 4, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2011.